6. Contributes to and supports the site team, which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products. Directly participates in internal audits or reviews.

7. Hires, integrates and develops high quality talent, capable of delivering against the department's goals and objectives.

8. Establish and communicates performance objectives for Quality Assurance staff that are consistent with the businesses unit goals and Quality and site objectives. Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment that enhances unit performance and integration across site departments.

Qualifications:

Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related

discipline, or its equivalent is required

A minimum of 10 years experience in biopharmaceutical quality with two years of prior supervisory experience desirable Experience in building and growing an organization into a high performance team.

Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics manufacturing with direct accountability for final product release.

Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable. Knowledge of US and EU cGMP regulations and guidance.

Knowledge and proven experience in FDA, EMA, or other regulatory authority. Demonstrated leadership, interpersonal, communication, and motivation skills. Knowledge of applicable business systems including SAP, LIMS, Maximo and Trackwise.

Knowledge of manufacturing executions systems such as Syncade, SmartLab; and distributive control systems such as